A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
7 augustus 2019 bijgewerkt door: Corcept Therapeutics
An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects
The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
Studie Overzicht
Gedetailleerde beschrijving
The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood.
Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces.
Safety and tolerability were assessed.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
9
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Nottinghamshire
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Nottingham, Nottinghamshire, Verenigd Koninkrijk, NG11 6JS
- Quotient Clinical
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])
- Age 30 to 65 years of age
- A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Male participants must agree to use an adequate method of contraception
- Participants are willing to abide by the study restrictions
Exclusion Criteria:
- Participation in a clinical research study within the previous 3 months
- Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
- Females of childbearing potential (female participants must have a negative urine pregnancy test)
- Male Participants with pregnant partners
- Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
- Positive drugs of abuse test result
- Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Amount of radioactivity eliminated in urine
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in urine and feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cumulative amount of radioactivity eliminated in urine
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cumulative amount of radioactivity eliminated in feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cumulative amount of radioactivity eliminated in urine and feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: peak plasma concentration (Cmax)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: time to reach maximum observed concentration (tmax)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: elimination half-life (t1/2)
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Metabolic profiling and structural identification in plasma, urine and feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Hematology
Tijdsspanne: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Clinical chemistry
Tijdsspanne: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Urinalysis
Tijdsspanne: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Blood pressure
Tijdsspanne: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Heart rate
Tijdsspanne: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Electrocardiogram
Tijdsspanne: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Percentage of subjects with adverse events
Tijdsspanne: Screening to Day 28
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Screening to Day 28
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Physical examination
Tijdsspanne: Screening and Day 8
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Screening and Day 8
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Tlag of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cmax of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Tmax of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUClast of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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%AUCextrap of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUCinf of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Lambda-z of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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T1/2 of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Mean Residence Time (MRT) of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent oral clearance (CL/F) of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent volume of distribution (Vz/F) of CORT125134
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of circulating radioactivity in plasma
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in urine
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in feces
Tijdsspanne: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Pui Leung, MBChB, Quotient Clinical
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2016
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
6 december 2016
Eerst ingediend dat voldeed aan de QC-criteria
23 februari 2017
Eerst geplaatst (Werkelijk)
1 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 augustus 2019
Laatste update ingediend die voldeed aan QC-criteria
7 augustus 2019
Laatst geverifieerd
1 augustus 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CORT125134-121
- 2016-000668-41 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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